Status:
NOT_YET_RECRUITING
Comparing Vacuum-Assisted Percutaneous Excision to Open Surgical Excision for Borderline or High-Risk Breast Lesions
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions:
Breast Fibroadenoma
Atypical Ductal Hyperplasia
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This randomized controlled trial compares vacuum-assisted percutaneous excision to open standard surgical excision in women who have high-risk or borderline, non-malignant breast lesions with respect ...
Detailed Description
In women diagnosed with high-risk or borderline, non-malignant breast lesions, is vacuum-assisted percutaneous excision (VAPE) comparable to open standard surgical excision with respect to efficacy, s...
Eligibility Criteria
Inclusion
- Women over age 18 with a core biopsy proven borderline or high-risk breast lesion that requires further excision for management based on the surgeon's assessment
- Informed consent must be obtained.
Exclusion
- Women who are considered high-risk based on a greater than 25% lifetime risk of breast cancer as per the IBIS (International Breast Cancer Intervention Study) Breast Cancer Risk Evaluation Tool
- Pathology that is felt to be discordant with imaging
- Extensive calcifications extending more than 20 mm and/or masses greater than 30 mm
- The following lesions will be excluded based on their increased risk of upstaging; lesions (other than fibroadenomas, phyllodes and papillomas) that are associated with a palpable mass, ADH (atypical ductal hyperplasia) with high-risk features (ADH with zonal necrosis, significant cytological atypia or more than 2 foci), LCIS (lobular carcinoma in situ) with high-risk features (associated with ADH, pleomorphic LCIS, zonal necrosis and \> 4 foci) or discordant with imaging, papilloma with atypia, and spindle cell lesion (especially if there is atypia).
- Lesions that are suspicious for borderline or malignant Phyllodes, DCIS (ductal carcinoma in situ), invasive mammary carcinoma, or encapsulated papillary carcinoma
- Any lesion that either the radiologist, pathologist or surgeon feels is not amenable to VAPE or surgical excision
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03868475
Start Date
January 1 2025
End Date
January 1 2028
Last Update
December 22 2023
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